Webcast

The Future of LDT Oversight

This is a recorded version of an AACC live webinar that was held April 22, 2015. In October 2014, the FDA published draft guidance outlining how the agency plans to regulate laboratory developed tests (LDTs) using a risk-based approach that, if implemented, would have significant implications for clinical laboratories. Since the release of the draft guidance, numerous stakeholders—ranging from clinicians and hospitals to commercial laboratories and disease-specific advocacy groups—have expressed concerns about the agency’s proposed approach to LDT regulation, and have recommended substantial changes. Some have even hinted at potential legal action, possible congressional involvement, and are floating their own proposals for how LDTs should be regulated. Order this 60-minute webinar and learn what these developments mean for the future of LDT oversight.